Long-term use of nonsteroidal anti-inflammatory drugs for pain control in patients with osteoarthritis: results of the 12-month observational study AELITA (Analgesia: Effective Treatment Using The Therapeutic Algorithm)

Non-steroidal anti-inflammatory drugs (NSAIDs) are the primary means of managing chronic osteoarthritis (OA) pain. The choice of NSAIDs is based on an analysis of the risk of adverse reactions (ARs). Objective: to evaluate the efficacy and safety of long-term use of NSAIDs for pain control in patients with OA in real clinical practice.

Patients and methods. To assess the results of long-term use of NSAIDs in OA, a 12-month observational non-interventional study was conducted. It included 611 patients with knee, hip and generalized OA, and nonspecific back pain associated with OA of the facet joints. All patients were prescribed aceclofenac (Aertal®) 200 mg/day. The patients' condition was assessed 2 weeks, 3, 6, 9 and 12 months after the start of therapy. The following parameters were determined: the intensity of pain during movement and the general health assessment (GA) according to the visual analogue scale (VAS, 10 cm); pain intensity according to the Likert verbal rating scale (VRS) (0–4); the number of patients with a pain reduction of ≥50% from baseline; patients' assessment of the result of therapy according to Likert VRS (1–5). The development of ARs was recorded at each visit.

Results and discussion. By month 12, 46.8% of patients had dropped out of observation. In patients who continued the study, the average severity of pain according to the VAS at baseline, after 2 weeks, 3, 6, 9 and 12 months was: 6.5±1.2; 4.8±1.4; 3.2±1.4; 2.6±1.4; 2.2±1.1; 1.4±1.1 cm, respectively (significant differences compared to the baseline for all points – p<0.05). The same differences were obtained in GA assessment.

Within the indicated time frame, the number of patients with moderate / severe pain (on the Likert scale) decreased from 77.8 to 24.9; 2.9; 2.3; 0.9 and 0%, respectively. The number of patients with a pain reduction of ≥50% from baseline was 12.0; 65.1; 81.0; 88.5 and 84.0%, respectively. A good or excellent assessment of treatment results after 2 weeks was given by 63.3% of patients, and after 12 months – by 95.6%. ARs were observed in about 30% of patients, mainly mild or moderate dyspepsia (in 11.1–23.3%) and arterial hypertension (in 7.1–10.9%). No serious ARs were registered.

Conclusion. Aceclofenac is an effective and relatively safe drug for the long-term management of chronic pain in OA.

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